ORAL HEALTHCARE ALLIANCE AGREEMENT
Exhibit 10.53
This ORAL HEALTHCARE ALLIANCE AGREEMENT (this “Agreement”), effective as of November
4th, 2005 (the “Effective Date”), is made by and between Introgen Therapeutics, Inc., a
Delaware corporation, having a principal place of business at 000 Xxxxxxxx Xxx, Xxxxx 0000, Xxxxxx,
Xxxxx, 00000 (“Introgen”), and Colgate-Palmolive Company, a Delaware corporation, having a
principal place of business at 000 Xxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx, 00000 (“Colgate”).
Introgen and Colgate are referred to herein as individually as a “Party” and collectively
as the “Parties”.
BACKGROUND
A. Introgen owns or controls proprietary technology and know-how relating to anti-cancer
products, and is in the business of researching and developing such products. As of the Effective
Date, Introgen’s lead product, known as Advexin, is in late stage clinical trials, and it has other
anti-cancer products at various stages of clinical development;
B. Colgate is a leader in the commercialization and marketing of oral hygiene products, and is
interested in developing and marketing products to oral healthcare professionals to treat oral
cancer and abnormal cell proliferation in the oral cavity;
C. Introgen and Colgate desire to form an alliance directed to the Field, pursuant to which
(i) Colgate shall purchase from Introgen shares of Common Stock valued at Twenty Million Dollars
(US$20,000,000) pursuant to the Stock Purchase Agreement, of even date herewith, between Introgen
and Colgate (the “Stock Purchase Agreement”), and (ii) Introgen shall design and implement
a research and development program with the goal of identifying potential Products in the Field and
developing one or more selected Products in the Field on the terms and conditions described herein;
D. Colgate desires, and Introgen desires to grant Colgate, certain rights of first negotiation
with respect to Products in the Field and/or the entire Field, all on the terms and conditions
described herein.
NOW, THEREFORE, in consideration of the covenants, conditions and undertakings hereinafter set
forth, it is agreed by and between the Parties as follows:
ARTICLE 1
DEFINITIONS
DEFINITIONS
As used herein, the following terms will have the meanings set forth below:
1.1 “Affiliate” of a person means (i) any other person or entity (each a “Controlling
Person”) of which such person is a direct or indirect subsidiary and (ii) all entities that are
direct or indirect subsidiaries of such person or such Controlling Person. For purposes of this
Agreement, an entity will be deemed to be a subsidiary of a Controlling Person if more than 50% of
the capital stock or
other equity interests of such entity are “beneficially owned” (as such term is defined in
Rule 13d-3 of the Exchange Act) directly or indirectly by such Controlling Person or if such
Controlling Person and its other direct or indirect subsidiaries have the right to elect a majority
of the members of the
board of directors or other governing body of such entity whether by
ownership of voting securities, by contract or otherwise.
1.2 “Change of Control” means, with respect to a person, the occurrence of any of the
following events:
(i) any “person” or “group” (as such terms are used in Sections 13(d) and 14(d) of the
Exchange Act, is or becomes the “beneficial owner” (as defined in Rule l3d-3 under the Exchange
Act), directly or indirectly, of more than 50% of the total voting power of the outstanding capital
stock of such person or 50% of the total number of outstanding shares of capital stock of such
person;
(ii) such person merges with or into, or consolidates with, or consummates any reorganization
or similar transaction with, another person and, immediately after giving effect to such
transaction, less than 50% of the total voting power of the outstanding capital stock of the
surviving or resulting person is “beneficially owned” (within the meaning of Rule 13d-3 under the
Exchange Act) in the aggregate by the stockholders of such person immediately prior to such
transaction;
(iii) in one transaction or a series of related transactions, such person, directly or
indirectly (including through one or more of its subsidiaries) sells, assigns, conveys, transfers,
leases or otherwise disposes of, all or substantially all of the assets or properties (including
capital stock of subsidiaries) of such person, but excluding sales, assignments, conveyances,
transfers, leases or other dispositions of assets or properties (including capital stock of
subsidiaries) by such person or any of its subsidiaries to any direct or indirect wholly-owned
subsidiary of such person;
(iv) individuals who as of the date hereof constituted the Board of Directors of such person
(or any new directors whose election by such Board of Directors, or whose nomination for election
by the stockholders of such person, was approved by a vote of a majority of the directors then
still in office) cease for any reason to constitute a majority of the Board of Directors of such
person then in office; or
(v) the liquidation or dissolution of such person.
1.3 “Collaboration Product” means a Product approved in writing by (or reflected in
the mutually agreed minutes of) the Steering Committee under Section 2.1.2 for development under
the Program. It is understood that a Product described in the last sentence of Section 1.7 (i.e.,
a Product for which a Phase II Trial has been initiated under the Program), as well as the [*]
Products proposed by Introgen under Section 2.1.2 shall in any event be deemed Collaboration
Products.
1.4 “Common Stock” means shares of common stock, par value of $0.001 per share, of
Introgen.
1.5 “Completion of Phase II” means, with respect to a Product in the Field: (a) that
one or more Phase II Trials of such Product have been conducted by or on behalf of Introgen and (b)
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Introgen has met with the FDA to review plans to proceed to a Pivotal Trial of such
Product, without receiving objection from the FDA that would prevent the commencement of a Pivotal
Trial of such Product. For such purposes, an “objection” from the FDA will mean that the FDA makes
clear to Introgen at the time of such meeting, as reflected in the minutes of such meeting (or the
FDA otherwise notifies Introgen in writing within sixty (60) days after such meeting), that the
Product would not be approvable based on the results of the proposed Pivotal Trial, or that the
Product would not be approvable unless additional Phase II studies were undertaken before starting
such Pivotal Trial. The “minutes” of such meeting shall be the version of the minutes distributed
by the FDA within sixty (60) days after such meeting, or if the FDA does not distribute such
meeting minutes (or such written notice) within such 60-day period, then as reflected in the
minutes of the meeting prepared by Introgen and provided to the FDA as Introgen’s proposed draft of
the minutes, provided that Introgen has received confirmation (by telephone or letter, for example)
that the FDA does not disagree in a material way with such minutes.
1.6 “Dominant Field IP” means [*].
1.7 “Exchange Act” means the Securities Exchange Act of 1934, as amended.
1.8 “FDA” means the United States Food and Drug Administration or any successor
agency.
1.9 “Field” means [*].
1.10 “FTE” means a dedicated full-time scientific person year, or in the case of less
than a full-time dedicated scientific person year, a full-time, equivalent scientific person year,
based upon a total of [*] weeks or [*] hours per year of scientific work, carried out by Introgen
Personnel.
1.11 “FTE Rate” shall initially be [*] per FTE per year, and shall be determined by
[*]; the FTE Rate shall be subject to correction from time to time in accordance with Section 2.5
below, so as to reflect the actual internal research and development costs incurred by Introgen to
perform Program activities, determined in accordance with GAAP, on a per-FTE basis, provided that
it is understood that the FTE Rate shall not include any costs to the extent such costs are already
within the Includable R&D Costs under clause (b) and (c) of Section 1.13. Attached as Exhibit 1.11
hereto is an example calculation of the FTE Rate for calendar year 2004.
1.12 “GAAP” means United States generally accepted accounting principles, consistently
applied.
1.13 “Includable R&D Costs” means amounts expended during the term of this Agreement
that are specifically directed to the Program, as follows: (a) internal costs for Introgen
Personnel that are performing activities that comprise the Program, at the FTE Rate based on hours
actually worked; (b) the actual amount of incremental out-of-pocket costs (e.g. amounts paid to
Third Party contract research organizations, testing services or the like not previously included
in the FTE Rate); (c) the Manufacturing Cost of Product materials manufactured or obtained by
Introgen used in the Program; and (d) with respect to work performed by third parties that is
funded by a grant obtained by Introgen or its collaborator, the amount of the grant funding, but
only to the extent such grant is directed to work that is directly related to the Program and is
approved by the Steering Committee.
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Includable R&D Costs shall be calculated in accordance with
GAAP. With respect to (d), it is understood that such grant funding may include expenses that are
applied by the university or institution at which the work is being performed, as a flat percentage
of the grant, where the university/institution charges a percentage of the grant to cover
unspecified costs, such as the costs of the physical laboratories and facilities, benefits of
employees working in the lab, and other costs, and that the full amount of such grant funding, to
the extent specifically directed to the Program (including a pro-rata portion of such percentage
charges to the extent normal and customary for such university/institution) will be Includable R&D
Costs. In no event shall the same item of expense be included in more than one of (a), (b), (c) or
(d) above for a given period (i.e., in no event shall the same item of expense be “double
counted”).
1.14 “Introgen Personnel” means an employee of Introgen or one of its Affiliates.
1.15 “Manufacturing Cost” means (a) if the Products are manufactured in whole or in
part by Introgen itself, the actual costs incurred by Introgen in producing such Products, and (b)
if the Products are manufactured by a supplier other than Introgen, the amounts paid by Introgen
for such Products to such supplier, plus the costs incurred by Introgen in procuring such supply
(such as QA/QC, handling and the like). Manufacturing Costs, whether determined under (a) or (b)
of this Section, shall be calculated in accordance with GAAP, consistently applied.
1.16 “No-Go Determination” means a determination by the Steering Committee or by an
arbitrator pursuant to Sections 2.2.3 and 8.1 that [*].
1.17 “person” means any individual, partnership, firm, corporation, limited liability
company, association, trust, unincorporated organization or other entity, as well as any syndicate
or group that would be deemed to be a person under Section 13(d)(3) of the Exchange Act.
1.18 “Phase II Trial” means a human clinical trial that includes one or more end
points pertaining to evaluation of dose ranges and/or a preliminary determination of efficacy in
patients being studied and that meets the requirements of 21 CFR §312.21(b).
1.19 “Pivotal Trial” means a human clinical trial that is intended to be sufficiently
powered and designed to establish safety and efficacy of one or more particular doses in the
patients being studied and to provide the statistical and clinical basis for obtaining marketing
approval of a Product.
1.20 “Product” means an active pharmaceutical ingredient comprising a gene or genes
expressing a protein capable of treating, preventing and/or reducing abnormal cell proliferation,
in a particular form, formulation or delivery system within the Field.
1.21 “Program Technology” means all inventions and know-how created or developed by a
Party which are applicable to the Field and all patent and other intellectual property rights
therein.
1.22 “Third Party” means a person or entity other than Introgen, Colgate and their
respective Affiliates.
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1.23 Other. In calculating a period expressed as a number of months, a month will be
calculated from the particular day of the first month, until the preceding day of the following
month (e.g., the period from August 5 through September 4 would be one month). In addition, the
following terms shall have the meanings defined in the corresponding Sections below.
Term | Section Defined | |
“Acquired Introgen Shares” |
7.3.2 | |
“Agreement” |
Preamble | |
“Colgate” |
Preamble | |
“Confidential Information” |
4.1 | |
“Contingent Right” |
3.4.4 | |
“Effective Date” |
Preamble | |
“Election Notice” |
3.2.2 | |
“Established
Pharmaceutical Company” |
3.2.4 | |
“Program” |
2.1.2 | |
“Steering Committee” |
2.2 | |
“Stock Purchase Agreement” |
Recitals | |
“Introgen” |
Preamble | |
“Joint Developments” |
4.4.2 | |
“[*]” |
3.3 | |
“Negotiation Period” |
3.2.2 | |
“Party” or “Parties” |
Preamble | |
“Permitted Licensing Window” |
3.2.2 | |
“Plan” |
2.1.1 | |
“Product Negotiation Right” |
3.1.1(a) | |
“Subject Area” |
3.2.1 | |
“Transfer Notice” |
7.3.2 | |
“Transferred” |
7.3.2 | |
“Trigger Notice” |
3.2.1 |
ARTICLE 2
THE PROGRAM
THE PROGRAM
2.1 Nature of the Collaboration. Subject to the terms and conditions of this
Agreement, Introgen shall conduct research and development activities directed to the Field as part
of a collaborative Program as set forth herein. As between the Parties, Introgen shall be
responsible for conducting the research and development activities of the Program and shall keep
Colgate informed, through the Steering Committee described below, as to the progress thereof, and
will consult with the Steering Committee regarding the direction and goals of the Program, all as
described in this Article 2. In addition, Colgate may from time to time undertake additional
activities relating to the Program, as Colgate may determine or the Parties agree, and will keep
the Steering Committee informed of those activities.
2.1.1 Initial Design of the Program; Product Options. Promptly following the
Effective Date, and in consultation with Colgate and the Steering Committee members, Introgen will
prepare a written summary of Introgen’s planned activities under the Program for consideration
by the Steering Committee, including the definition of a desired profile for a lead Product in the
Field to develop and potentially commercialize, and potential Product candidates to meet that
profile, and a non-binding estimated budget for the next fiscal year (collectively, the
“Plan”). Introgen shall update the Plan at least annually, including providing a
non-binding, estimated budget for the then upcoming fiscal year.
2.1.2 Program Parameters. After approval by the Steering Committee of the initial
plan for the Program, Introgen shall present to the Steering Committee a reasonable number of
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options for Products within the Field, not including any Product(s) for which clinical testing has
been conducted prior to the Effective Date. During the course of the Program, Introgen shall
present to the Steering Committee alternatives for [*] Products in the Field, together with
preclinical data as to safety and efficacy providing reasonable support, as determined by the
Steering Committee, for each such Product alternative. Based on such initial data, and from time
to time thereafter, the Steering Committee shall determine the Products in the Field with respect
to which Introgen shall focus its efforts in the Program, based on biological performance, ease of
manufacturing, cost, safety, and other factors deemed appropriate by the Steering Committee. The
Products selected, and the activities with respect to identifying, presenting, researching,
developing and manufacturing Products in the Field, shall be reviewed on an ongoing basis by the
Steering Committee, and may be revised or refined from time to time as the Steering Committee
determines (collectively, such Products and activities, as the same may be changed from time to
time in accordance with this Agreement, the “Program”).
2.2 Steering Committee. The Parties shall promptly after the Effective Date establish
a committee (the “Steering Committee”) to coordinate and oversee the Program.
2.2.1 Composition. The Steering Committee shall include not more than three (3)
representatives from each of Colgate and Introgen, with each Party’s members selected by that
Party. Introgen and Colgate may each replace its Steering Committee representatives at any time,
upon written notice to the other Party; provided that each Party shall at all times have at least
one representative who is at the level of vice president or above of such Party.
2.2.2 Meetings. The Steering Committee shall meet as frequently as agreed by the
Parties, but in no case less frequently than once every six (6) months, at such locations as the
Parties agree, and will otherwise communicate as appropriate by telephone, electronic mail, video
conference or the like. With the consent of the Parties, other representatives of Introgen or
Colgate may attend Steering Committee meetings as nonvoting observers. Either Party may call a
meeting of the Steering Committee on ten (10) days written notice, which meeting will be held
telephonically if requested by either Party.
2.2.3 Decisions. Decisions of the Steering Committee shall be by unanimous vote of
its members, provided that at least one (1) representative of each Party participates in such vote.
In the event the Steering Committee cannot reach unanimity on an issue within its scope of
authority, the matter shall be referred to Colgate’s senior executive responsible for research and
development and Introgen’s Chief Executive Officer, who shall promptly meet to discuss and
resolve the matter. If such officers do not resolve such matter within thirty (30) days after
such referral, Introgen shall have the right to cast the deciding vote with respect to such
matters, other than to make a No-Go Determination, and such deciding vote shall be deemed the
decision of the Steering Committee. If such officers cannot agree as to a No-Go Determination,
then such matter shall be resolved in accordance with Section 8.1 below (it being understood that
the arbitrator shall determine whether [*]).
2.3 Introgen Efforts. During the term of this Agreement, Introgen shall use
commercially reasonable efforts to implement the Program, including endeavoring as part of the
Program (a) to
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access grant funding therefor and (b) to take one or more Product(s) in the Field
approved by the Steering Committee to Completion of Phase II. Notwithstanding the other provisions
of this Article 2, however, Introgen’s obligations under this Article 2 shall be deemed fully
satisfied (and Introgen shall thereafter have no further obligations under this Article 2) if
either: (a) the aggregate Includable R&D Costs incurred after the Effective Date and during the
term of this Agreement equals at least [*], or (b) the Steering Committee makes a No-Go
Determination, whichever of (a) or (b) occurs first.
2.4 Statement of Includable R&D Costs. Prior to May 1 of each year of the Program,
Introgen shall provide Colgate with a statement of the Includable R&D Costs for the prior year
(“Statement of Costs”), including a calculation of the FTE Rate reflecting the actual costs
as described in Section 1.11 for such prior year. Colgate will have a period of sixty (60) days
after receipt of the Statement of Costs to request a review of the calculation of the Includable
R&D Costs and/or FTE Rate for the prior year, and in connection with such request, Introgen shall
provide to Colgate documentation reasonably requested by Colgate to confirm the calculation of
Includable R&D Costs and FTE Rate in such Statement of Costs. If so requested by Colgate, the
Parties shall review and resolve within sixty (60) days thereafter the actual Includable R&D Costs
and FTE Rate applicable for the prior year. In lieu of Colgate’s review, if Introgen so desires,
the review may be completed by Introgen’s external public accounting firm after which a letter,
attesting that the Includable R&D Costs were calculated in accordance with Section 1.11 above,
will be issued to Introgen with a copy to Colgate. Upon issuance of such letter or, in the case of
a review by Colgate, upon the Parties’ resolution of all disputed amounts, or if Colgate does not
request to review the Statement of Costs within 60-days after its receipt, the Includable R&D Costs
in such Statement of Costs (or as otherwise agreed by the Parties) for such year shall be deemed
final and binding on the Parties for all purposes of this Agreement.
2.5 Colgate Cooperation. Colgate shall collaborate with Introgen in Introgen’s
performance of the Program through the device of the Steering Committee, and by conducting such
additional activities relating to the Program as Colgate may determine or agree to conduct, but
Colgate shall not be obligated to make available to the Program any particular Colgate technology.
From time to time during the term of this Agreement, Colgate shall review its technology portfolio
to determine whether any of it is relevant to the Program and further determine, as may be agreed
by the Parties in writing, whether to license any such technology to Introgen for use in connection
with the Program. If Colgate offers, in its sole discretion, to make available to the Program any
particular Colgate technology, the Parties shall first enter into a separate written agreement with
respect to such Colgate technology on terms that are mutually agreed upon by the Parties. Such
terms may include, if
Colgate so requires, compensation to Colgate (e.g. in the form of royalties) with respect to
commercialization of products incorporating such technology other than by Colgate. Any tangible
samples of materials or formulations will be shared by the Parties pursuant to separate written
material transfer agreements, in form and substance mutually agreeable to the Parties.
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Confidential treatment has been requested with respect to the omitted portions.
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ARTICLE 3
COLGATE PRODUCT RIGHTS
COLGATE PRODUCT RIGHTS
3.1 Activities in the Field.
3.1.1 Introgen. During the term of this Agreement, other than as specifically set
forth in this Article 3, Introgen shall not: (i) [*], or (ii) [*]; or (iii) [*]. Subject to
Colgate’s rights under this Article 3, Introgen shall have the right to grant to Third Parties
development, manufacturing, marketing and/or distribution rights with respect to Products in the
Field as follows:
(a) Introgen may grant rights of the type referred to in Section 3.1.1 above with respect to a
Product, [*]. If Introgen is permitted to grant such rights with respect to such Product, the
grant may extend to [*]. Colgate’s right of first negotiation, as described in Section 3.2 below,
with respect to any such grant of rights for such Product under this Paragraph (a) is referred to
as the “Product Negotiation Right”;
(b) Introgen may grant rights of the type referred to in Section 3.1.1 above with respect to
some or all of the Field, including without limitation one or more particular Product(s) [*],
following [*]; provided that either (A) the aggregate Includable R&D Costs over the term of this
Agreement equals at least [*], or (B) the Steering Committee has determined that [*]. Colgate’s
right of first negotiation, as described in Section 3.2 below, with respect to any such grant of
rights under this Paragraph (b) is referred to as the “Field Negotiation Right”;
(c) If Introgen proposes to grant rights to a Third Party as permitted by Paragraph (a) or (b)
above, it shall first offer such rights to Colgate in accordance with Section 3.2 below.
3.1.2 Exclusivity of Efforts.
(a) Until the earliest of (i) termination of this Agreement; (ii) the seventh (7th)
anniversary of the Effective Date or (iii) such time as Colgate may have Transferred to
non-Affiliates of Colgate, in one or more transactions, more than the percentages of Acquired
Introgen Shares set forth in Sections 7.3.2(a), (b) and (c), during the applicable time periods set
forth therein, Colgate will not [*], except in collaboration with Introgen under an agreement
entered into pursuant to the Product Negotiation Right or the Field Negotiation Right or as
otherwise agreed by the Parties.
(b) Notwithstanding anything herein to the contrary:
(i) If a Third Party is acquired by Introgen pursuant to a Change of Control transaction or a
Third Party acquires Introgen pursuant to a Change of Control, the Product
Negotiation Rights and Field Negotiation Rights (and the obligations and restrictions on
Introgen described in this Article 3) will apply only to products (including Products) in the Field
that (A)
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were developed or marketed by Introgen prior to such Change of Control transaction or (B)
were developed by such acquiror or acquired Third Party based on use of Program Technology after it
acquires Introgen or Introgen acquires it, as applicable; in no case shall Colgate’s Product
Negotiation Rights or Field Negotiation Rights (nor any terms of Article 3, including Section
3.1.1) apply to products controlled by such Third Party prior to such Change of Control transaction
and any modifications or derivatives thereof, or products that are developed after such Change of
Control transaction not based on use of Program Technology. For clarity, it is understood and
agreed that in the event of a Change of Control of Introgen, the provisions of this Article 3
(including Section 3.1.1) shall only apply to the intellectual property rights controlled by
Introgen prior to or after such Change of Control transaction, and shall not apply to any
intellectual property rights of the Third Party.
(ii) If a Third Party is acquired by Colgate pursuant to a Change of Control transaction or a
Third Party acquires Colgate pursuant to a Change of Control, the limitations in Section 3.1.2(a)
will not apply to activities of the acquired or acquiring entity with respect to products that (A)
were developed or marketed by the acquired or acquiring entity prior to such Change of Control
transaction or (B) were developed by such acquiror or acquired entity not based on use of Program
Technology after it acquires Colgate or Colgate acquires it, as applicable; in no case shall
3.1.2(a) apply to activities of the Third Party with respect to products controlled by such Third
Party prior to such Change of Control transaction and any modifications or derivatives thereof, or
products that are developed by such Third Party after such Change of Control transaction not based
on use of Program Technology.
(iii) In addition, if Colgate is acquired by a Third Party pursuant to a Change of Control
transaction, Introgen and the acquiror shall meet promptly to discuss in good faith how best to
achieve the goals of the Program. If within the [*] period following the date of the Change of
Control, Introgen and the acquiror do not reach agreement on such topics or agree that they can
otherwise work effectively and cooperatively together, then either Party shall have the right to
terminate this Agreement upon thirty (30) days written notice to the other Party.
(iv) For clarity, investments by Colgate in a person (A) that is not an Affiliate of Colgate
and (B) with whom Colgate has no agreement or arrangement to cooperate, collaborate, or have any
rights relating to [*], and no right to acquire control of such person or such rights shall not be
considered to be “development or commercialization” for purposes of Section 3.1.2(a) above.
Unrestricted grants and other unrestricted funding of academic or non-profit researchers or
institutions by Colgate shall not be considered “development or commercialization” for purposes of
Section 3.1.2(a) above, or otherwise prohibited by this Section 3.1.
3.2 Procedures upon Trigger of Field Negotiation Rights or Product Negotiation Rights.
3.2.1 Trigger Notice. Prior to any grant of rights under Section 3.1.1(a) or (b) to a
Third Party, Introgen shall notify Colgate in writing that a Product Negotiation Right or the Field
Negotiation Right is being triggered and provide [*] (“Trigger Notice”). In any event,
Introgen shall
promptly notify Colgate after the conditions that would allow Introgen to trigger Colgate’s
Product Negotiation Right or Field Negotiation Right, as the case may be, have been satisfied;
provided,
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however that such notice of condition satisfaction will not be deemed to be a
Trigger Notice unless Introgen specifically identifies it as such at the time of delivery. The
Product(s) described in the Trigger Notice in accordance with Section 3.1.1(a), and the portion of
the Field described in the Trigger Notice in accordance with Section 3.1.1(b) above is referred to
below as the “Subject Area.”
3.2.2 Election to Negotiate. In the event Colgate notifies Introgen in writing within
[*] days after Colgate’s receipt of the Trigger Notice that it is interested in pursuing a
transaction within the scope of the Trigger Notice (the “Election Notice”), Introgen and
Colgate shall negotiate in good faith towards mutually acceptable terms and conditions of such a
transaction (it being understood that the marketing and distribution rights (including any
Contingent Rights to market and/or distribute) offered to Colgate in such transaction would be, and
the manufacturing and development rights offered to Colgate may be, exclusive within the Field).
If the Parties have not entered into a written agreement with respect to such transaction within
[*] days after the date Colgate receives the Trigger Notice (“Negotiation Period”), then
for a period of [*] months after the expiration of the Negotiation Period (the “Permitted
Licensing Window”), Introgen shall be free to grant to one or more Third Party(ies) some or all
of the development, manufacturing, marketing and/or distribution rights and/or Contingent Rights
for Products within the Subject Area; [*]. If Colgate does not provide an Election Notice to
Introgen within [*] days after the Trigger Notice, or if after delivering the Election Notice and
during the Negotiation Period Colgate does not agree to enter into a transaction on the terms last
proposed by Introgen and/or does not offer to Introgen in writing alternative terms under which
Colgate would agree to enter into a transaction within the Subject Area, then Introgen shall be
free to grant to one or more Third Parties, development, manufacturing, marketing and/or
distribution rights and/or Contingent Rights for, or develop, manufacture, market and/or distribute
itself the Product (in the case of the Product Negotiation Right having been triggered) or
Products within the Subject Area (in the case of the Field Negotiation Right having been
triggered), on such terms and/or under such conditions as Introgen considers appropriate without
further obligation to Colgate under this Section 3.2.
3.2.3 Re-triggering the Negotiation Rights. Introgen may re-trigger the Product
Negotiation Right or Field Negotiation Right, as the case may be, for some or all the Subject Area
by so notifying Colgate in writing referring to this Section 3.2.3, [*]. Upon receipt of such
notice, the Parties shall repeat the procedures of Section 3.2.1 and 3.2.2 above, amended as set
forth in this Section 3.2.3, with such notice serving as a Trigger Notice, except that the
Negotiation Period shall be only [*] days from the date Colgate receives such Trigger Notice. For
clarity, it is understood that if the Parties do not enter into an agreement granting exclusive
rights to Colgate with respect to the Subject Area set forth in such Trigger Notice during such
Negotiation Period, then the Permitted Licensing Window for the Subject Area described in the most
recent Trigger Notice delivered by Introgen to Colgate shall be [*] months after the end of the
Negotiation Period under this Section 3.2.3 (subject to further re-triggering under this Section
3.2.3).
3.2.4 Commercialization by Introgen. After a Product Negotiation Right or Field
Negotiation Right has been triggered and Introgen has (a) [*], and (b) [*], then Introgen shall
have the right to conduct, on its own (directly or through contractors), any and all development,
manufacturing, marketing and/or distribution within such Subject Area. Notwithstanding the
foregoing or Section 3.1.1 above, this Article 3 shall not be deemed to prohibit Introgen
[*] Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.
10
manufacturing, developing, marketing and/or distributing Products within the Field in accordance
with an agreement with a Third Party entered into in compliance with Colgate’s Product Negotiation
Rights or Field Negotiation Rights (for example, if such agreement provides Introgen with
development, manufacturing, co-promotion or co-marketing/distribution rights). In addition, once
Introgen has commenced marketing and/or distribution, directly or through contractors, within a
Subject Area in accordance with this Section 3.2.4, the Product Negotiation Rights and Field
Negotiation Rights (i.e., Colgate’s rights and Introgen’s obligations under this Article 3) and the
procedures set forth in this Article 3 with respect to such Subject Area shall be suspended unless
and until [*]. Notwithstanding the foregoing, in the event Introgen is acquired by an Established
Pharmaceutical Company (as defined below) pursuant to a Change of Control transaction, this Section
3.2.4 shall only apply with respect to those Subject Areas described in the applicable Trigger
Notices for which conditions (a) and (b) of this Section 3.2.4 were satisfied prior to such Change
of Control and with respect to those Products for which a [*] has been made prior to such Change of
Control. As used herein, an “Established Pharmaceutical Company” shall mean a company with
annual worldwide pharmaceutical sales over [*] in the last full fiscal year ending prior to the
date of such Change of Control.
3.3 [*]
3.4 Additional Procedures; Matters.
3.4.1 Term Sheet Level. The negotiations to be pursued under Section 3.2, [*], may be
conducted at the term sheet level, and may not include all of the terms and conditions of the
definitive agreement but the Parties may be bound only by such definitive agreement. [*].
3.4.2 Trigger Notice not Exclusive. If Introgen triggers the Field Negotiation Right
in accordance with Section 3.1.1(b) above, it is understood that such Trigger Notice under Section
3.1.1(b) may include any Subject Area for which Introgen has previously provided a Trigger Notice
in accordance with Section 3.1.1, subject to any definitive written agreements previously entered
into between the Parties with respect to such Subject Area following the Trigger Notice in
accordance with this Article 3.
3.4.3 Certain Permitted Arrangements. The restrictions and obligations of Introgen
under this Article 3 (including those restrictions under Section 3.1.1 and 3.2 above) shall be
subject to this Section 3.4.3; in that Introgen may:
(a) Enter into development and manufacturing arrangements, and grant licenses and rights for
the purposes of such arrangements, all for the purposes of the Program, and the same shall not be
deemed to violate Section 3.1.1 or Section 3.2;
(b) Enter into agreements for contract manufacturing or other contract services for Third
Party(ies), [*], and the same shall not be deemed to violate Section 3.1.1(i); provided that, [*];
[*] Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.
11
(c) Grant non-exclusive licenses, [*] to a Third Party pursuant to a cross-license
arrangement with the Third Party, and the same shall not be deemed to violate Section 3.1.1(iii) or
Section 3.2; provided that [*]; and
(d) For clarity, the transactions described in (a), (b) and (c) shall not be subject to nor
deemed to violate Colgate’s Product Negotiation Rights or Field Negotiation Rights or any provision
of this Article 3. An amendment of an agreement described in this Section 3.4.3, other than [*],
shall not be deemed a new agreement or grant.
3.4.4 No Implied Obligations. The only obligations of Colgate and Introgen under
this Article 3 are as expressly stated herein, and there are no further implied obligations
relating to the matters contemplated therein. Without limiting the foregoing, but for example,
Introgen is not at any time obligated to [*]. It is further acknowledged and agreed that: (i) a
transaction by which a Third Party acquires substantially all of the business or assets of Introgen
will not be deemed subject to or to violate the Product Negotiation Right or Field Negotiation
Right, and this Article 3 shall not apply to such transaction, so long as the person so acquiring
substantially all of Introgen’s business or assets agrees in writing to abide by this Article 3 (as
limited by Section 3.1.2(b)(i)); and (ii) if Introgen enters into a transaction with a Third Party
in accordance with this Article 3 that includes the grant by Introgen of an option or other
contingent right to acquire rights to all or part of any Subject Area (each such option or right
being referred to as a “Contingent Right”), then the grant of rights by Introgen upon a
Third Party’s exercise of such Contingent Right shall not be subject to this Article 3 so long as
the grant of such Contingent Right was made in a transaction entered into with the Third Party in
compliance with this Article 3.
3.4.5 No Licenses Granted. It is understood that no license or other right to develop
or commercialize Products is granted under this Agreement to Colgate. Any such rights would be
granted only under a separate written agreement entered into by the Parties in accordance with this
Article 3 or otherwise agreed upon and executed by the Parties.
3.4.6 Colgate Rights in Field Not Limited to Oral Healthcare Professionals. For
clarity, notwithstanding any implication to the contrary in Paragraph B of the Background of this
Agreement, it is understood that the scope of this Agreement is not limited to oral healthcare
professionals, and includes the marketing of Products within the Field to others as well.
ARTICLE 4
INTELLECTUAL PROPERTY
INTELLECTUAL PROPERTY
4.1 Confidential Information. Except as otherwise expressly provided herein, the
Parties agree that the receiving Party shall not, except as expressly provided in this Article 4,
disclose to any Third Party (other than directors, officers, employees, agents, financial and legal
advisors and consultants of such Party who are under similar confidentiality obligations) or use
for any purpose any confidential information furnished to it by the disclosing Party hereto in
connection with this Agreement that was either (i) disclosed in a written or tangible form marked
“confidential” or with a similar legend, or (ii) was confirmed orally to be confidential at the
time of disclosure and confirmed
[*] Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.
12
in writing as confidential within a reasonable time thereafter (“Confidential
Information”), except to the extent that it can be established by the receiving Party that such
information:
(a) was already known to the receiving Party, other than under an obligation of
confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise part of the public domain at the time
of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the receiving Party in breach of this
Agreement; or
(d) was independently developed by the receiving Party without having used such Confidential
Information.
4.2 Permitted Use and Disclosures. Each Party hereto may use or disclose Confidential
Information disclosed to it by the other Party to the extent such use or disclosure is reasonably
necessary (a) in the exercise of rights expressly granted herein, or the performance of its
obligations, under this Agreement or in the performance of its obligations under any marketing or
distribution agreements between the Parties entered into pursuant to this Agreement, or (b) in
prosecuting or defending litigation or arbitration, complying with applicable governmental laws,
regulations or court order; provided that if a Party is required by law to make any such
disclosure, other than pursuant to a confidentiality agreement, it will give reasonable advance
notice to the other Party of such disclosure and will use its reasonable efforts to secure
confidential treatment of such information in consultation with the other Party prior to its
disclosure (whether through protective orders or otherwise) and disclose only the minimum necessary
to comply with such requirements.
4.3 Non-Disclosure of Terms. Subject to Section 5.1 below, each of the Parties agrees
not to disclose the terms of this Agreement to any Third Party without the prior written consent of
the other Party, which consent shall not be unreasonably withheld, except to such Party’s
attorneys, advisors, investors and others on a need to know basis under circumstances that
reasonably ensure the confidentiality thereof, or to the extent required by law (as determined by
the disclosing Party’s legal counsel).
4.4 Allocation of Ownership of Intellectual Property.
4.4.1 The Parties agree that, as between themselves, (i) each Party shall retain ownership of
the intellectual property of such Party in existence on the Effective Date and shall own all
inventions and technology (and the intellectual property rights therein) hereafter invented or
created by or on behalf of such Party and (ii) nothing in this Agreement shall be construed as
providing for the assignment or transfer of any ownership interest in either Party’s existing or
hereafter acquired intellectual property.
4.4.2 If, during the term hereof and as a result of activities under this
Agreement, any inventions, technology or intellectual property are invented or created jointly by
employees or
13
agents of each of the Parties (collectively, “Joint Developments”), each Party shall
own an undivided one-half (1/2) interest therein and shall be free to use, license and exploit such
Joint Developments in an unrestrictive fashion without any accounting to or consent of the other;
provided that the foregoing shall not be deemed to limit either Party’s obligations under Article 3
above. The Parties will consult with each other regarding whether a patent application should be
prepared, filed and prosecuted, and, once issued, maintained with respect to any invention that
constitutes a Joint Development.
4.4.3 In addition, to facilitate discussions between the Parties at the Steering Committee,
including scientific discussions, and other interactions from time to time, the Parties agree that
[*]. This Section 4.4.3 shall not be construed to grant either Party any licenses or rights with
respect to the patent rights or copyrights of the other Party.
ARTICLE 5
PUBLICITY
PUBLICITY
5.1 Public Statements. Colgate and Introgen shall attempt in good faith to consult
with each other before issuing, and provide each other the opportunity to review and comment upon,
any press release, filing with the Securities and Exchange Commission or other public statements
with respect to this Agreement, including, in the event Colgate does not issue a release on its own
or jointly with Introgen, with respect to pre-agreed questions and answers for potential inquiries
from Third Parties. Neither party shall issue any such press release or make any such public
statement prior to such good faith attempt to consult with the other party, except as may be
required by applicable law, by court process or by obligations pursuant to any listing agreement
with any securities exchange.
ARTICLE 6
REPRESENTATIONS AND WARRANTIES
REPRESENTATIONS AND WARRANTIES
6.1 Warranty. Each Party represents and warrants on its own behalf that: (i) it has
the legal power and authority to enter into this Agreement and to perform all of its obligations
hereunder; (ii) this Agreement is a legal and valid obligation binding upon it and enforceable in
accordance with its terms; and (iii) except as set forth on Schedule 6.1 hereto, it has not
previously granted, and during the term of this Agreement will not make any commitment or grant,
any rights which are in conflict with the rights granted herein (including, in the case of
Introgen, any right under any intellectual property rights owned by or licensed to Introgen that
would authorize any Third Party to develop, manufacture, market or distribute a product in the
Field in a manner that would violate the obligations of Introgen under Article 3) or deprive the
other Party of the benefits intended to be conferred by the Product Negotiation Right or the Field
Negotiation Right or this Agreement. Introgen further represents and warrants to Colgate that
neither it nor any of its subsidiaries is, nor by reason of giving effect to the consummation of
the transactions contemplated hereby will be, in default under the terms of any intellectual
property license agreement to which it is a party or by which it is bound or to which any of its
properties is subject. Colgate further represents and warrants that, as of the Effective Date, it
has not filed for or obtained patent rights that are specifically directed to Products in the
Field, or that would materially interfere with the commercialization of
[*] Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.
14
products in the Field, and Colgate will not file or obtain such patent rights based on any
invention conceived by Colgate personnel prior to the Effective Date.
6.2 Disclaimer. COLGATE AND INTROGEN SPECIFICALLY DISCLAIM ANY GUARANTEE THAT THE
PROGRAM WILL BE SUCCESSFUL, IN WHOLE OR IN PART. THE FAILURE OF THE PARTIES TO SUCCESSFULLY
DEVELOP PRODUCTS OTHER THAN IN BREACH OF THE TERMS HEREOF WILL NOT CONSTITUTE A BREACH OF ANY
REPRESENTATION OR WARRANTY OR OTHER OBLIGATION UNDER THIS AGREEMENT. EXCEPT AS OTHERWISE EXPRESSLY
SET FORTH IN THIS AGREEMENT OR THE STOCK PURCHASE AGREEMENT, INTROGEN AND COLGATE MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH
RESPECT TO THE PROGRAM TECHNOLOGY, PRODUCTS OR INFORMATION DISCLOSED HEREUNDER, INCLUDING, BUT NOT
LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF ANY
PROGRAM TECHNOLOGY, PATENTED OR UNPATENTED, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS
OF THIRD PARTIES.
ARTICLE 7
TERM AND TERMINATION
TERM AND TERMINATION
7.1 Term. The term of this Agreement shall commence on the Effective Date and, unless
terminated earlier in accordance with this Agreement, continue in full force and effect until the
seventh (7th) anniversary of the Effective Date.
7.2 Termination for Breach. Either Party to this Agreement may terminate this
Agreement in the event the other Party hereto shall have materially breached or defaulted in the
performance of any of its material obligations hereunder or under the Stock Purchase Agreement, and
such default shall have continued for thirty (30) days after written notice thereof was provided to
the breaching Party by the non-breaching Party. Any termination shall become effective at the end
of such thirty (30) day period unless the breaching Party has cured any such breach or default
prior to the expiration of the thirty (30) day period.
7.3 Termination Upon Notice.
7.3.1 By Colgate. Colgate may terminate this Agreement for any reason upon written
notice to Introgen.
7.3.2 By Introgen. Introgen shall have the right to terminate this
Agreement upon written notice to Colgate at any time after the first time at which Colgate has
Transferred to Third Party(ies), in one or more transaction(s), the following percentages of the
Acquired Introgen Shares:
(a) during the first [*] months after the Effective Date, Colgate has so Transferred [*] or
more of the Acquired Introgen Shares;
[*] Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.
15
(b) during the period commencing on the first day of the [*] month following the Effective
Date and ending on the last day of the [*] month following the Effective Date, Colgate has so
Transferred [*] or more of the Acquired Introgen Shares; or
(c) after the [*] month following the Effective Date, Colgate has so Transferred [*] or more
of the Acquired Introgen Shares.
Prior to Transferring (as defined in the Stock Purchase Agreement) any of the Acquired Introgen
Shares, Colgate shall notify Introgen in writing (each such notice, a “Transfer Notice”) of
its intent to Transfer such shares. [*] Colgate shall be permitted to deliver an unlimited number
of Transfer Notices to Introgen during the term of this Agreement. For purposes of this Section
7.3.2, “Acquired Introgen Shares” means the shares of Common Stock acquired by Colgate
pursuant to the Stock Purchase Agreement, and any securities issued as (or issuable upon the
conversion or exercise of any warrant, right or other security which is issued as) a dividend or
other distribution with respect to, in exchange for or in replacement of the shares of Common Stock
acquired by Colgate pursuant to the Stock Purchase Agreement.
7.3.3 Field Negotiation Right Exhausted. In the event Introgen has granted Third
Party(ies), in compliance with Article 3, all or substantially all rights to the Field, this
Agreement shall automatically terminate.
7.4 Effect of Termination or Expiration.
7.4.1 Accrued Rights and Obligations. Termination or expiration of this Agreement for
any reason shall not release either Party hereto from any liability which, at the time of such
termination, has already accrued to the other Party or which is attributable to a period prior to
such termination nor preclude either Party from pursuing any rights and remedies it may have
hereunder or at law or in equity with respect to any breach of this Agreement.
7.4.2 Survival. Articles 1 (Definitions), 4 (Intellectual Property), 8 (Dispute
Resolution) and 9 (Miscellaneous) and Section 7.4 of this Agreement shall survive the expiration or
termination of this Agreement for any reason.
ARTICLE 8
EXPEDITED RESOLUTION OF CERTAIN DISPUTES
EXPEDITED RESOLUTION OF CERTAIN DISPUTES
8.1 Product Right Dispute. In the event (i) of a dispute under Article 3,
or (ii) if the Steering Committee is unable to reach a unanimous decision as to whether a No-Go
Determination should be made under Section 2.2.3 above, or (iii) of a dispute under Section 2.4
above; then each such matter shall be resolved by arbitration in accordance with this Section 8.1.
Any such arbitration shall be conducted by JAMS in Chicago, Illinois, or such other location as
the Parties agree, in accordance with the JAMS Streamlined Arbitration Rules and Procedures, as
modified by Section 8.4 of this Agreement, by a single arbitrator appointed in accordance with such
Rules, or if the Rules do not provide for such appointment, by the chief executive officer of JAMS.
In the event of disputes as to [*] or as to a No-Go Determination, the arbitrator shall select an
expert who has at least ten (10) years experience in general management in the pharmaceutical
industry at the vice president level or
[*] Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.
16
above (including at least five years of such experience of a biotechnology company), or an
individual as nearly meeting such qualifications as is practicable as determined by the arbitrator,
to advise on the proposed resolution of the dispute; absent clear error (as determined by the
arbitrator), the arbitrator shall adopt the decision of such expert as the arbitrator’s decision.
8.2 Completion in 30 Days. In any arbitration under Section 8.1 above, the arbitrator
and the Parties shall use diligent efforts to resolve such dispute within thirty (30) days after
the selection of the arbitrator, or as soon thereafter as is practicable.
8.3 Costs. The costs of any arbitration under this Article 8 shall be shared equally
by the Parties and each Party shall bear its own expenses, provided that the arbitrator may require
the non-prevailing Party to bear 100% of such costs, and/or the direct expenses of the prevailing
Party to the extent the arbitrator determines that the non-prevailing Party pursued the dispute in
bad faith. The decision of the arbitrator shall be binding on the Parties, and in the event of a
No-Go Determination, shall be deemed the decision of the Steering Committee, and any judgment upon
such decision of the arbitrator may be entered and enforced in any court of competent jurisdiction.
8.4 Procedures. The Parties agree that the following procedures shall apply to each
arbitration proceeding conducted pursuant to this Article 8:
8.4.1 All papers, documents or evidence, whether written or oral, filed with or presented to
the arbitrator or expert referred to above shall be deemed by the Parties to this Agreement and by
the arbitrator and such expert to be Confidential Information. Neither Introgen, nor Colgate, nor
the arbitrator nor such expert shall disclose in whole or in part to any other person any
Confidential Information submitted in connection with an arbitration proceeding, except to the
extent reasonably necessary to assist in the arbitration, or to prepare for the arbitration, or to
the extent necessary to enforce an award made by the arbitrator.
8.4.2 Each Party shall be permitted to submit a written statement in support of their position
no later than fifteen (15) days after the arbitration proceeding has commenced. Each Party may
submit answering statements within five (5) days of the submission of the other Party’s initial
written statements. No further written statements shall be submitted, unless required by the
arbitrator.
8.4.3 A hearing, if necessary, shall occur within thirty (30) days after appointment of the
arbitrator. The Parties shall request that the arbitrator render its decision within five (5) days
after any such hearing.
8.4.4 The arbitrator shall be empowered to decide if he has jurisdiction over the dispute that
is the subject of the arbitration.
8.4.5 In making his or her determination hereunder, the arbitrator shall review the terms of
the Agreement and the written statement and any evidence submitted by the parties to the
arbitration proceeding in accordance with the provisions of this Article 8 and the substantive law
applicable to this Agreement.
17
8.5 Decision by the Arbitrator; Awards; Injunctive Relief. The arbitrator is
empowered to enjoin a Party from performing any act prohibited or to compel a Party to perform any
act which will give effect to the arbitrator’s decision with respect to the foregoing matters. The
arbitrator shall issue a written explanation of the reasons for its decision and a full statement
of facts found in reaching the decision. This determination of the arbitrator shall be rendered no
later than the fifth (5th) day after the conclusion of the arbitration proceedings. The arbitrator
shall not be empowered to award, whether based in contract, tort or otherwise, any punitive,
consequential, special, lost profits or exemplary damages. Each Party has the right before or, if
the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to
seek and obtain from the appropriate court provisional remedies such as attachment, preliminary
injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the
subject matter of the arbitration.
ARTICLE 9
MISCELLANEOUS
MISCELLANEOUS
9.1 Governing Laws. This Agreement and all disputes or controversies arising out of
or relating to this Agreement or the transactions contemplated hereby shall be governed by, and
construed in accordance with, the internal laws of the State of New York, without regard to the
laws of any other jurisdiction that might be applied because of the conflicts of laws principles of
the State of New York.
9.2 Submission to Jurisdiction. Except for those particular arbitration proceedings
described in Section 8.1, each of the Parties irrevocably aggress that any legal action or
proceeding arising out of or relating to this Agreement or for recognition and enforcement of any
judgment in respect hereof brought by the other Party or its successors or assigns may be brought
and determined in any Delaware Chancery Court or Superior Court or federal court sitting in
Delaware, and each of the parties hereby irrevocably submits to the exclusive jurisdiction of the
aforesaid courts for itself and with respect to its property, generally and unconditionally, with
regard to any action or proceeding arising out of or relating to this Agreement and the
transactions contemplated hereby (and agrees not to commence any action, suit or proceeding
relating thereto except in such courts). Each of the parties further agrees to accept service of
process in any manner permitted by such courts. Each of the parties hereby irrevocably and
unconditionally waives, and agrees not to assert, by way of motion or as a defense, counterclaim or
otherwise, in any action or proceeding arising out of or relating to this Agreement or the
transactions contemplated hereby, (a) any claim that it is not personally subject to the
jurisdiction of the above-named courts for any reason other than the failure lawfully to serve
process, (b) that it or its property is exempt or immune from jurisdiction of any such court or
from any legal process commenced in such courts (whether through service of notice, attachment
prior to judgment, attachment in aid of execution of such judgment, execution of judgment or
otherwise) and (c) to the fullest extent permitted by law, that (i) the suit, action or proceeding
in any such court is brought in any inconvenient forum, (ii) the venue of such suit, action or
proceeding is improper or (iii) this Agreement, or the subject matter hereof, may not be enforced
in or by such courts.
9.3 WAIVER OF JURY TRIAL. EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY
ARISING UNDER THIS AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES, AND THEREFORE
18
EACH SUCH PARTY HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT SUCH PARTY MAY HAVE TO
A TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO
THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT. EACH PARTY CERTIFIES AND
ACKNOWLEDGES THAT (A) NO REPRESENTATIVE, AGENT OR ATTORNEY OF THE OTHER PARTY HAS REPRESENTED,
EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO
ENFORCE THE FOREGOING WAIVER, (B) EACH SUCH PARTY UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS
OF THIS WAIVER, (C) EACH SUCH PARTY MAKES THIS WAIVER VOLUNTARILY, AND (D) EACH SUCH PARTY HAS BEEN
INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE WAIVES AND CERTIFICATIONS IN THIS
SECTION 9.3.
9.4 Waiver. It is agreed that no waiver by either Party hereto of any breach or
default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any
subsequent and/or similar breach or default.
9.5 Assignment. This Agreement shall not be assignable by either Party without the
written consent of the other Party hereto, except either Party may assign this Agreement, without
such consent, to an entity that acquires all or substantially all of the business or assets of such
Party whether by merger, reorganization, acquisition, sale, or otherwise; provided, however, that
the assignee agrees in writing to be bound by the terms and conditions of this Agreement.
9.6 No Fiduciary Obligations. The relationship of the Parties hereto is that of
independent contracting parties. The Parties are not deemed to be agents, partners or joint
venturers of the others for any purpose as a result of this Agreement or the transactions
contemplated thereby and no fiduciary duties or other obligations not specifically set forth herein
shall be implied or imputed to either Party.
9.7 Notices. All notices, requests and other communications hereunder
shall be in writing and shall be personally delivered or by registered or certified mail, return
receipt requested, postage prepaid, or overnight courier, in each case to the respective address
specified below, or such other address as may be specified in writing to the other Parties and
shall be deemed to have been given upon receipt:
Introgen:
|
Introgen Therapeutics, Inc. | |
000 Xxxxxxxx Xxxxxx, Xxxxx 0000 | ||
Xxxxxx, Xxxxx 00000 | ||
Attn: Xxxxx Xxxxx, CEO | ||
Fax: (000) 000-0000 |
19
With a copy to:
|
Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx | |
Professional Corporation | ||
000 Xxxx Xxxx Xxxx | ||
Xxxx Xxxx, Xxxxxxxxxx 00000-0000 | ||
Attn: Xxxxxxx X. Xxxxx, Esq. | ||
Fax: (000) 000-0000 | ||
Colgate:
|
Colgate-Palmolive Company | |
000 Xxxx Xxxxxx | ||
Xxx Xxxx, Xxx Xxxx 00000 | ||
Attn: Xxxxxx X. Xxxxxx, Esq. | ||
Fax: (000) 000-0000 | ||
With a copy to:
|
Xxxxxx, Xxxx & Xxxxxxxx LLP | |
000 Xxxx Xxxxxx | ||
00xx Xxxxx | ||
Xxx Xxxx, Xxx Xxxx 00000-0000 | ||
Attn: Xxxxx Xxxx, Esq. | ||
Fax: 000-000-0000 |
9.8 Force Majeure. Neither Party shall lose any rights hereunder or be liable to the
other Party for damages or losses (except for payment obligations) on account of failure of
performance by the defaulting Party if the failure is occasioned by war, strike, fire, Act of God,
earthquake, flood, lockout, embargo, governmental acts or orders or restrictions, failure of
suppliers, or any other reason where failure to perform is beyond the reasonable control and not
caused by the negligence, intentional conduct or misconduct of the non-performing Party and such
Party has exerted all reasonable efforts to avoid or remedy such force majeure; provided, however,
that in no event shall a Party be required to settle any labor dispute or disturbance.
9.9 Complete Agreement. This Agreement, including the Exhibits and Schedules hereto,
and the Stock Purchase Agreement constitute the entire agreement, both written and oral, between
the Parties with respect to the subject matter hereof, and all prior agreements, including, without
limitation, the Outline of Terms and the Confidentiality Disclosure Agreement, dated [*], between
the Parties, respecting the subject matter hereof, either written or oral, express or implied,
shall be abrogated, canceled, and are null and void and of no effect. No amendment or change
hereof or addition hereto shall be effective or binding on either of the Parties unless reduced to
writing and executed by the respective duly authorized representatives of Introgen and Colgate.
9.10 Specific Performance. Each of the Parties acknowledges and agrees that the other
Party hereto may be damaged irreparably in the event of any of the provisions of this Agreement are
not performed in accordance with their specific terms or otherwise are breached. Accordingly, each
of the parties hereto agrees that the other Party hereto shall be entitled to seek an injunction
(notwithstanding any pending or ongoing arbitration or litigation proceedings) to prevent breaches
of
[*] Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.
20
the provisions of this Agreement and if appropriate and entitled to do so under applicable law,
to enforce specifically this Agreement and the terms and provisions hereof in any court in
accordance with Section 9.2 hereof, in addition to any other remedy to which they may be entitled
at law or in equity.
9.11 Headings. The captions to the several Sections and Articles hereof are not a
part of this Agreement, but are included merely for convenience of reference and shall not affect
its meaning or interpretation.
9.12 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed to be an original and all of which together shall be deemed to be one and the
same agreement.
[Remainder of Page Intentionally Left Blank]
21
IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed by their authorized
representatives and delivered in duplicate originals as of the Effective Date.
COLGATE-PALMOLIVE COMPANY | INTROGEN THERAPEUTICS, INC. | |||||
By: | /s/ Xxxxxx X. Xxxxxx | By: /s/ Xxxxx X. Xxxxxxxx, Xx. | ||||
Name:
|
Xxxxxx X. Xxxxxx | Name: Xxxxx X. Xxxxxxxx, Xx. | ||||
Title:
|
Vice President R&D Oral Care | Title: Chief Financial Officer | ||||
EXHIBIT 1.11
FTE RATE CALCULATION
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[*] Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.
SCHEDULE 6.1
NO CONFLICTS
None.